RESTORE Trial: A Pilot RCT of Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) for Veterans With CPTSD

Complex Post-Traumatic Stress Disorder Clinical Trial

Official title:

RESTORE Trial: A Pilot RCT of Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) vs. Treatment as Usual (TAU) for Complex Posttraumatic Stress Disorder (CPTSD) in Military Personnel

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04752072
• Other study ID #: SHSC2686062
• Secondary ID: FiMT19/0429EDU
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2021
• Est. completion date: February 2023

Study information

• Verified date: April 2022
• Source: Combat Stress
• Contact: Dominic Murphy, Prof.
• Phone: 01372 587 017
• Email: dominic.murphy[@]combatstress.org.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Complex Post traumatic Stress Disorder (CPTSD) is now recognized as a separate trauma-based psychological condition to PTSD. CPTSD is a broader diagnosis that includes the core PTSD symptoms (re-experiencing in the here and now, avoidance, and sense of current threat) plus an additional set of symptoms that are collectively referred to as 'disturbances in self-organisation' (DSO). DSO symptoms capture pervasive psychological disturbances that are associated with traumatic exposures and that are distributed across three clusters: difficulties in affect regulation (AR), negative self-concept (NSC), and disturbances in relationships (DR).

There are no effective interventions for CPTSD. It is therefore of paramount important to identify effective interventions to treat veterans with CPTSD. The present study will be one of the first to investigate the effectiveness of a novel, modular intervention for CPTSD. Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) is a person-centered intervention that involves targeting the symptoms of CPTSD clusters sequentially using concrete modules (i.e., specific number of sessions targeting specific clusters of symptoms).

The overall aim of this study is to establish the feasibility, acceptability and preliminary effects of ESTAIR in treating CPTSD. To achieve these aims, the investigators will conduct a pilot randomised controlled trial (RCT), with a sample of 60 military veterans meeting the diagnostic criteria for CPTSD, and with two treatment arms: ESTAIR vs. a treatment-as-usual (TAU) condition.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (18 years or older) in the caseload of Combat Stress

• Armed forces veteran (United Kingdom)

• Help-seeking for trauma-related psychological distress

• Meeting diagnostic criteria for CPTSD, as measured by the ITQ (Cloitre et al., 2018)

• Proficiency in English language

• Signed informed consent provided

Exclusion Criteria:

• Severe psychotic disorder (defined by previous clinical diagnosis)

• Current alcohol or drug use disorder

• Serious cognitive impairment

• Planned concurrent additional treatment

Related Conditions & MeSH terms

• Complex Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Enhanced Skills Training in Affective and Interpersonal Regulation
The first (formulation) session enables linking present difficulties and traumatic events, identifying current issues/concerns, and collaboratively agreeing on the order of modules based on symptom severity and client readiness. The PTSD module provides narrative exposure to the traumatic memories and targets re-experiencing, avoidance and hyperarousal symptoms. The AD module focuses on identifying and labelling feelings, emotion management, distress tolerance, acceptance of feelings and experiencing positive emotions. The NSC module focuses on staying in the present moment and combating dissociation; self-compassion and mindfulness skills; challenging thinking patterns and developing a balanced view of self. The DR module focuses on exploring and revising maladaptive schemas; effective assertiveness; awareness of social context; and flexibility in interpersonal expectations and behaviours displayed in social interactions.
• Treatment as usual
The first session will involve a mental health assessment by either a psychiatrist or psychologist. A treatment package will be developed based on the information collected during the assessment. Details of the interventions delivered to each participant receiving TAU, which will include elements of psychoeducation, symptom-management and trauma-focused cognitive behaviour therapy, will be recorded.

Locations

Country	Name	City	State
United Kingdom	Combat Stress	Leatherhead	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
Combat Stress	Edinburgh Napier University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (8)

Cloitre M, Shevlin M, Brewin CR, Bisson JI, Roberts NP, Maercker A, Karatzias T, Hyland P. The International Trauma Questionnaire: development of a self-report measure of ICD-11 PTSD and complex PTSD. Acta Psychiatr Scand. 2018 Dec;138(6):536-546. doi: 10.1111/acps.12956. Epub 2018 Sep 3. — View Citation

Cloitre, M., Karatzias, T., Mc Glanaghy, E. (2019). Enhanced STAIR Narrative Therapy for CPTSD. Treatment Manual. Unpublished Manuscript.

Gray MJ, Litz BT, Hsu JL, Lombardo TW. Psychometric properties of the life events checklist. Assessment. 2004 Dec;11(4):330-41. — View Citation

Hutton P, Byrne R, Pyle M, Morrison AP. Adverse Effects of Psychological Therapy Questionnaire. Unpublished; 2015.

Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. — View Citation

Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. — View Citation

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Experience of potentially traumatic life events on the Life Events Checklist (LEC)	The LEC (Gray et al., 2004) is a 17-item questionnaire assessing potentially traumatic events in the respondent's lifetime. The LEC assesses exposure to 16 events plus one item assessing any other extraordinary stressful event. Respondents report whether they 1) directly experienced, 2) witnessed, 3) learned about, 4) are not sure, or 5) does not apply to them.	Baseline
Other	Rates of adverse events at end of treatment and 3-months follow up	Using a previously applied approach (adapted from Klingberg et al., 2012), we will define serious adverse events as (i) death by suicide; (ii) suicide attempt; (iii) suicidal crisis without attempt; (iv) severe symptom exacerbation (increase of 2 standard deviations or more on the patient or researcher-rated ITQ. Non-severe adverse events will be defined as a score of =3 (agree 'quite a lot' or 'a lot') on any relevant item (e.g., subjectively worsening mental state, heightened stigma, increased medication use, increased conflict) on the patient-rated Adverse Events Questionnaire (adapted from Hutton et al., 2015).; Participants who withdraw from the study will also be asked to complete the Adverse Events Questionnaire (adapted from Hutton et al., 2015) to determine whether withdrawal is due to adverse events.	End of treatment (week 25) and 3-months follow up (week 37)
Other	Change in symptoms of CPTSD on the International Trauma Questionnaire (ITQ) following each module in ESTAIR arm only	The ITQ (Cloitre et al., 2018) is described above as the primary outcome measure. Six items represent the three clusters of PTSD. Another six items represent the three clusters reflecting disturbances in self-organisation (DSO). The remaining items assess functional impairment relating to symptoms of PTSD (3 items) and DSO (3 items). Items are scored using 5-point Likert scales ranging from 0 (not at all) to 4 (extremely), indicating how much a symptom has affected them in the past month.; The ITQ will be completed following each module in the ESTAIR arm to gain insight into the progression of CPTSD symptoms during treatment and to support discontinuation of treatment should any adverse symptom exacerbation occur.	Week 7, Week 13, Week 19, Week 25
Other	Change in symptoms of the moral injury on the 14-item Moral Injury Outcome Scale (MIOS) from baseline to 3-months follow-up	The MIOS (Litz et al., 2020) is a 14-item questionnaire of moral injury. Items are scored using 5-point Likert scales ranging from 0 (strongly disagree) to 3 (strongly agree), indicating how much they would agree with each statement in the past month. Total scores range from 0 to 60, with higher scores indicating greater severity of moral injury.; *Due to further validation work, the MIOS has been amended from a 15-item measure to a 14-item measure of moral injury.	Baseline and 3-months follow up (week 37)
Other	Qualitative data regarding acceptability of the ESTAIR intervention (ESTAIR arm only)	Participants completing the ESTAIR intervention will have a one-off interview to collect information regarding their experiences of treatment in general, the protocol, and overall participation.; Client will provide their subjective experience of the intervention, including positive and negative aspects of the treatment, the impact on their wellbeing, and be asked to offer suggestions for improvement.	End of treatment (Week 25)
Primary	Retention rate at the end of treatment	Percentage of clients completing intervention and completing outcome measures at the end of treatment.	Post-treatment (week 25)
Primary	Retention rate at 3-months follow up	Percentage of clients completing intervention and completing outcome measures at 3-months follow up.	3-months follow-up (week 37)
Primary	Change in symptoms of CPTSD on the International Trauma Questionnaire (ITQ) from baseline to end of treatment to 3-months follow up	The ITQ (Cloitre et al., 2018) is a validated questionnaire assessing PTSD and complex-PTSD (CPTSD). Six items represent the three clusters of PTSD (re-experiencing, avoidance and sense of threat), while another six items represent the three clusters reflecting disturbances in self-organisation (DSO) (AD: affective dysregulation; NSC: negative self-concept; and DR: disturbances in relationships. The remaining items assess functional impairment relating to symptoms of PTSD (3 items) and DSO (3 items). Items are scored using 5-point Likert scales ranging from 0 (not at all) to 4 (extremely), indicating how much a symptom has affected them in the past month.; A diagnosis of CPTSD required a diagnosis of PTSD (at least one symptom of each of its three clusters as well as functional impairment) in addition to endorsement of at least one symptom of each of the three DSO clusters plus functional impairment.	Baseline, end of treatment (week 25) and 3-months follow up (week 37)
Secondary	Change in symptoms of depression on the 9-item Patient Health Questionnaire (PHQ-9) from baseline to end of treatment to 3-months follow up	The PHQ-9 (Korienke et al., 2001) is a 9-item questionnaire of depression. Items are scored using 4-point Likert scales ranging from 0 (not at all) to 3 (nearly every day), indicating how much they have been bothered by a symptom over the past two weeks. Total scores range from 0 to 27, with higher scores indicating greater levels of depression. Cut-off scores of 15 are used to identify participants likely meeting criteria for depressive disorder.	Baseline, end of treatment (week 25) and 3-months follow up (week 37)
Secondary	Change in symptoms of generalised anxiety on the 7-item Generalised Anxiety Disorder Questionnaire (GAD-7) from baseline to end of treatment to 3-months follow up	The GAD-7 (Spitzer et al., 2006) is a 7-item questionnaire of generalised anxiety. Items are scored using 4-point Likert scales ranging from 0 (not at all) to 3 (nearly every day), indicating how much they have been bothered by a symptom over the past two weeks.; Total scores range from 0 to 21, with higher scores indicating greater levels of anxiety. Cut-off scores of 10 are used to identify participants likely meeting criteria for generalised anxiety disorder.	Baseline, end of treatment (week 25) and 3-months follow up (week 37)
Secondary	Change in alcohol use on the 3-item (AUDIT-C) from baseline to end of treatment to 3-months follow up	The AUDIT-C (Saunders et al., 1993) consists of the first three items of the Alcohol Use Disorders Identification Test. Items are scored using a 4-point Likert scale. Total scores range from 0 to 12. Based on a nationally representative sample of adults from the United States, scores = 4 effectively capture a diagnosis of Alcohol Use Disorder (AUD).	Baseline, end of treatment (week 25) and 3-months follow up (week 37)
Secondary	Change in medically unexplained symptoms on the 15-item Patient Health Questionnaire-15 (PHQ-15) from baseline to end of treatment treatment to 3-months follow up	The PHQ-15 (Korienke et al., 2002) is a 15-item questionnaire of somatisation disorder symptoms. Items are scored using 4-point Likert scales ranging from 0 ("not bothered at all") to 3 ("bothered a little" or "nearly every day"), indicating how much they have been bothered by a symptom over the past two weeks. Total scores range from 0 to 30, with scores of of =5, =10, =15 representing mild, moderate and severe levels of somatization.	Baseline, end of treatment (week 25) and 3-months follow up (week 37)
Secondary	Outcome on the single item Friends and Family Test (FFT) at end of treatment.	The FFT is a single item assessing the acceptability of an intervention (i.e., ' How likely is it that you would recommend our service to your GP, family and friends if they needed similar care?'). The item is scores on a 5-point Likert scale ranging from 1 ("extremely unlikely") to 5 ("extremely likely". The FFT is standardly administered as an end-of-treatment measure at Combat Stress	End of treatment (week 25)